Percutaneously accessing and securing internal organs or other target tissue within a patient

Abstract

A novel device and system for percutaneously accessing and securing target tissue / organs within a patient for interventional diagnosis or treatment and methods for the same. The access device includes an elongated tube having a lumen therethrough configured to engage a tissue via suction, and a clamping element slidably disposed within the elongated tube configured to move from an open position to a closed position in which tissue that is pushed into the elongated tube when suction is applied is pinched between the clamping element and the elongated tube thereby holding an area of tissue exposed at an open end of the elongated tube such that it can be accessed from outside the body of the patient through the tube. The system may include the novel device and a trocar having an awl and a rigid, hollow cannula tube.

Description

BACKGROUND This invention relates generally to the field of surgical devices and, more particularly, to clamping or grasping devices for engaging bodily tissue that can be used to hold the tissue firmly during medical procedures, such as surgery. During surgery it is often necessary to engage and hold bodily tissue or organs to allow access to, and / or though the tissue or organ. Thus, specific instruments are required capable of engaging, clamping, and holding tissues and / or organs, often through small access incisions. For example, for the diagnosis and therapy of small intestine disorders, minimally invasive surgery such as endoscopic surgery and laparoscopic surgery shows the advantages of less invasiveness, having fewer adverse events, and shorter hospital stays as compared with open surgery, but the length of small intestine (with an average adult length of about 7 meters (23 feet)) is a substantial challenge for minimally invasive surgery. Preliminary clinical data have shown that novel image-guided percutaneous endoscopic small bowel surgery (PESBS) is superior to conventional therapy in several aspects including the success rate in the treatment of small bowel obstruction (SBO), and it is very likely that a new field of minimally invasive treatment of small intestine disorders will be presented before us. However, this new approach has not been fully explored due to the lack of suitable instruments. One of the main issues is the lack of an anchoring / stabilizing device that can safely and reliably fix specific small intestine loops for instrumentation or wound closure. For example, during advancement of a conventional catheter set commonly used in clinics for this procedure, T-fasteners are used as anchoring devices. The T-fasteners are made up of a short (e.g., no more than a centimeter long) piece of a wire or cannula with a suture (either resorbable or permanent) attached in its middle. Upon introduction, using a needle, the T-fastener is deployed inside the bowel, and the suture is pulled back, thereby pulling the T-fastener against the bowel wall, which in turn pulls the bowel wall to stabilize it against the abdominal wall. The benefit of the T-fastener is its small profile for placement. However, once the bowel is stabilized with the T-fastener, a second site of access is required, usually near the location of the T-fastener, to allow entry of devices / treatments needed to treat the diseased portion of the bowel. Furthermore, the T-fastener only provides limited support and stabilization of the bowel wall against the abdominal wall. Another conventional anchoring / stabilizing device to engage and hold bodily tissue or organs during medical procedures is a surgical clamp. Conventional surgical clamps require two generally parallel elements, or jaws, that are movable in relation to each other and are torqued together to squeeze tissue positioned between the two jaws, similar to forceps or alligator clips, for instance. However, while these types of conventional clamps are useful to grasp and manipulate tissue, they do not readily - 1 - allow access to, and / or through the portion of tissue held in the jaws of the clamp, for instance, during PESBS or similar procedures where it is often desirable and / or necessary to engage a targeted area of tissue, such as the wall of an organ, while allowing access to and / or through that area of tissue for local delivery of, for example, therapeutic and / or diagnostic substances, additional surgical instruments, equipment and / or devices, etc. Another drawback to these conventional clamps is that each jaw grasps the tissue from opposing sides, but in procedures like PESBS where only one surface of the target tissue is exposed, the conventional clamp is ineffective. Further, these conventional devices often require an independent delivery system, and extra space at the engagement site to open and close their jaws. Another main issue is the lack of a secure closing device for the access opening in the intestinal wall. Percutaneous access opening must currently be enlarged through the incision to allow surgical closure. Therefore, an innovative percutaneous access platform that provides access to internal organs or other target tissues, including the small intestine (and / or any part of the intestine), within a patient is urgently needed to help overcome the major obstacles mentioned above, which is crucial for the progress of minimally invasive interventions, including for the diagnosis and therapy of small intestine disorders / diseases. SUMMARY Accordingly, disclosed herein are devices, systems, and methods for use by a surgeon during surgery, including PESBS, for percutaneously accessing and engaging, clamping, manipulating and / or moving the tissue and / or organs of a surgical patient, including in the small intestine (and / or any part of the intestine). Furthermore, at least some of the disclosed embodiments provide access to and / or through a targeted area of the tissue / organs for local delivery of, for example, therapeutic and / or diagnostic substances, additional surgical instruments, equipment and / or devices, etc., for interventional diagnosis and / or treatment. In at least one embodiment of a device for engaging bodily tissue and / or organs according to the present disclosure, the device comprises an elongated tube and a compactor slidably positioned within the tube. The elongated tube comprises a proximal end, a distal end, and defines a vacuum channel running therethrough from the proximal end to the distal end, a vacuum port in communication with the proximal end of the tube, the vacuum port being operatively connected to the vacuum channel and capable of operative connection to a vacuum source, an engagement rim at the distal end of the tube comprising a suction port in communication with the vacuum channel, the suction port configured to releasably engage a surface of a tissue forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port, and wherein at least a portion of the surface of the tissue is pushed within the engagement rim by external pressure when the vacuum source is applied through the vacuum channel. The engagement rim further comprises one or more flanges around the circumference of the inner wall of the tube at the engagement ring protruding radially inward from the inner wall. In at least one embodiment, the compactor comprises a generally cylindrical body having a proximal end, a distal end, and a lumen defined therethrough along the length of the compactor, the compactor further having one or more ridges formed on an outer surface of the compactor configured to cooperatively interact with the one or more flanges inside the engagement rim of the tube. The compactor is configured to move between at least a first position and a second position, wherein when the compactor is in the first position, the compactor is spaced away from the engagement rim and vacuum can be applied to the device thereby causing tissue to be pushed by external pressure into the engagement rim through the suction port at the distal end of the tube, and when the compactor is moved to the second position while vacuum is still being applied, the one or more ridges of the compactor cooperatively interact with the one or more flanges in the engagement rim thereby causing the flanges and the ridges to pinch, or clamp the tissue therebetween. In at least one embodiment, the engagement rim comprises a plurality of flanges, and the compactor comprises an equal number of ridges. In at least one embodiment the compactor is generally castellated to form the ridges and radial channels therebetween on the outer surface of the compactor. The present disclosure includes disclosure of a device for engaging bodily tissue and / or organs, comprising an elongated tube, a compactor positioned within the tube configured to move from a first position to at least a second position within the tube, and a driver configured to move the compactor between its first and second positions within the tube. In at least one embodiment of a device for engaging bodily tissue and / or organs according to the present disclosure, the device comprises an elongated outer tube and in inner tube slidably positioned within the tube. The elongated tube comprises a proximal end, a distal end, and defines a vacuum channel running therethrough from the proximal end to the distal end, the proximal end of the tube being operatively connected to a vacuum source, an engagement rim at the distal end of the tube comprising a suction port in communication with the vacuum channel, the suction port configured to releasably engage a surface of a tissue forming a reversible seal with the surface of the tissue when a vacuum source is applied to the vacuum channel, and wherein at least a portion of the surface of the tissue is pushed within the engagement rim by external pressure when the vacuum source is applied through the vacuum channel. In at least one embodiment, the inner tube has a distal end and a proximal end, and defines a lumen therethrough from the distal end to the proximal end. The inner tube may further comprise one or more ridges formed on an outer surface thereof. The inner tube is configured to move between at least a first position and a second position, wherein when the inner tube is in the first position, the distal end of the inner tube is spaced away from the engagement rim and vacuum can be applied to the device thereby causing tissue to be pushed by external pressure into the engagement rim through the suction port at the distal end of the outer tube, and when the inner tube is moved to the second position while vacuum is still being applied, the one or more ridges at the distal end of the inner tube engage the engagement rim thereby pinching, or clamping the tissue therebetween. In at least one embodiment of a system for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the system comprises a percutaneous access device, for example, as described herein, a trocar having an awl (which may be metal or plastic with a pointed or tapered tip) and a rigid, hollow cannula tube, and may be configured for advancement through the abdominal wall of a patient. The present disclosure includes disclosure of a method for using a device to engage bodily tissue and / or organs the method comprising the steps of inserting an elongated tube into a patient at or near the targeted tissue and / or organ, wherein the elongated tube comprises a proximal end, a distal end, and defines a vacuum channel running therethrough from the proximal end to the distal end, a vacuum port in communication with the proximal end of the tube, the vacuum port being operatively connected to the vacuum channel and capable of operative connection to the vacuum source, an engagement rim at the distal end of the tube comprising a suction port in communication with the vacuum channel, the suction port configured to releasably engage a surface of a tissue forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port; attaching the distal end of the elongated tube to the targeted tissue and / or organ via suction wherein at least a portion of the surface of the tissue is pushed through the suction port into the engagement rim by external pressure; and advancing a compactor through the elongated tube to pinch, or clamp the tissue between the compactor and the tube. The present disclosure includes disclosure of a method for using a device to engage bodily tissue and / or organs the method comprising the steps of inserting a percutaneous access device having an elongated outer tube and an inner tube slidably disposed within the elongated outer tube into a patient at or near the targeted tissue and / or organ, wherein the elongated outer tube comprises a proximal end, a distal end, and defines a vacuum channel running therethrough from the proximal end to the distal end, the proximal end of the outer tube being operatively connected to the vacuum source, an engagement rim at the distal end of the outer tube comprising a suction port in communication with the vacuum channel, the suction port configured to releasably engage a surface of a tissue forming a reversible seal with the surface of the tissue when a vacuum source is applied to the vacuum channel, and wherein the inner tube has a distal end and a proximal end, and defines a lumen therethrough from the distal end to the proximal end; attaching the distal end of the elongated outer tube to the targeted tissue and / or organ via suction wherein at least a portion of the surface of the tissue is pushed through the suction port into the engagement rim by higher external pressure; and advancing the inner tube through the elongated outer tube to pinch, or clamp the tissue between the distal end of the inner tube and the rim of the outer tube. The present disclosure includes a method for using a percutaneous access device as described herein to access the small intestine (SI) the method comprising the steps of inserting a needle (e.g., a Veress open tip needle) through the abdominal wall, placing a guide wire through the needle and across the abdominal wall, injecting contrast and methylene blue, removing needle out over guide wire, advancing trocar over guidewire and across the abdominal wall, removing the awl of the trocar leaving the cannula in place, advancing the percutaneous access device over the guide wire and through cannula of trocar, such that a distal end of an elongated engagement tube of the access device contacts an external surface of the SI, applying suction to the access device thereby causing at least a portion of the tissue of SI wall to be pushed into the distal end of the engagement tube by higher external pressure, actuating a driving mechanism of the access device thereby causing an inner tube slidably disposed within the engagement tube to move from a first, open position to a second closed position thereby pinching, or clamping the tissue of the SI wall between a distal end of the inner tube and the distal end of the outer tube. The present disclosure includes a method for using a percutaneous access device as described herein to access the small intestine (SI) the method comprising the steps of inserting a needle (e.g., a Veress open tip needle) through the abdominal wall, placing a guide wire through the needle and across the abdominal wall, injecting contrast and methylene blue, removing needle out over guide wire, advancing the percutaneous access device over the guide wire, the percutaneous access device such that a distal end of an elongated engagement tube of the access device contacts an external surface of the SI, applying suction to the access device thereby causing at least a portion of the tissue of SI wall to be pushed into the distal end of the engagement tube by higher external pressure, actuating a driving mechanism of the access device thereby causing an inner tube slidably disposed within the engagement tube to move from a first, open position to a second closed position thereby pinching, or clamping the tissue of the SI wall between a distal end of the inner tube and the distal end of the outer tube. The access site of the SI wall is held securely and continuously to the engagement tube to provide a stabilized area accessible via the lumen of the inner tube and through which instruments (such as introducer sheath, endoscope, dilation balloon, or closure device) can be inserted. After diagnosis or treatment, a closure device may be introduced through the access device, or alternatively, a closure device may be incorporated into the access device. When advancing the access device, the method may further include using a camera, or scope to guide the access device. BRIEF DESCRIPTION OF THE DRAWINGS The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein: FIG. 1 shows a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 2 shows a sectional view of the novel clamping device of FIG. 1; FIG. 3 shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIGS. 4A-4B show perspective views of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 4C shows a bottom view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 4D shows a sectional view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 5A shows a sectional distal end side view of a novel clamping device with compactor in retracted mode, according to an exemplary embodiment of the present disclosure; FIG. 5B shows a sectional distal end side view of a novel clamping device with compactor in clamping mode, according to an exemplary embodiment of the present disclosure; FIGS. 6A-6B show various steps in the method of use of a novel clamping device / system, according to an exemplary embodiment of the present disclosure. FIG. 7 shows a perspective view of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 8 shows an exploded view of a novel clamping device without vacuum tube attached, according to an exemplary embodiment of the present disclosure; FIGS. 9A-9B show sectional views of the novel clamping device of FIG. 7 in the open and closed positions; FIGS. 10A-10B show sectional views of the distal end of the novel clamping device of FIG 7 in the open and closed positions; FIG. 11A shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 1 IB shows a bottom view of the component of a novel clamping device depicted in FIG. 11 A; WO 2025 / 175319                                   PCT / US2025 / 018231 FIG. 11C shows a top view of the component of a novel clamping device depicted in FIG. 11 A; FIG. 12 shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 13 shows a perspective view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 14 shows a sectional perspective view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 15 shows a sectional perspective view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 16 shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 17 shows a perspective view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 18 shows a side perspective view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 19 shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 20 shows a perspective view of a component of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIG. 21 shows a sectional side view of a subassembly of components of a novel clamping device, according to an exemplary embodiment of the present disclosure; FIGS. 22A-22B show a side view of a novel clamping device, according to an exemplary embodiment of the present disclosure with the stabilizing ring in the retracted and deployed positions; An overview of the features, functions and / or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described. Some of these non-discussed features, as well as discussed features are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and / or configuration. DETAILED DESCRIPTION For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made in detail to exemplary embodiments of the present invention, examples of which are illustrated in the accompanying drawings. It is to be understood that other embodiments may be utilized and structural and functional changes may be made without departing from the respective scope of the invention. Moreover, features of the various embodiments may be combined or altered without departing from the scope of the invention. It is to be understood that the present invention is not limited to the particular methodology, compounds, materials, manufacturing techniques, uses, and applications, described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. As such, the following description is presented by way of illustration only and should not limit in any way the various alternatives and modifications that may be made to the illustrated embodiments and still be within the spirit and scope of the invention. Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include the plural reference unless the context clearly dictates otherwise. Thus, for example, a reference to "a suture" is a reference to one or more sutures and includes equivalents thereof known to those skilled in the art. The materials that may be used in conjunction with the present invention may include conventional materials such as stainless steel, other surgical alloys of steel, various biocompatible plastics and elastomers, and other conventional materials. In general it may be valuable to avoid using materials that are likely to cause allergic reactions or inflammation, unless such a result is desired. The described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination. As used herein, the words “example” and “exemplary” mean an instance, or illustration. The words “example” or “exemplary” do not indicate a key or preferred aspect or embodiment. The word “or” is intended to be inclusive rather than exclusive, unless context suggests otherwise. As an example, the phrase “A employs B or C,” includes any inclusive permutation (e.g., A employs B; A employs C; or A employs both B and C). In the present disclosure, the term “distal” is used to refer to the part of the device farthest from an operator or closest to a patient. The term “proximal” is used to describe the part of the device closest to an operator or farthest from a patient. For example, the part of the device that is inserted into the patient first will be the distal part. The devices, systems, and methods of the present application will be described in the context of an access and engagement system for percutaneous small bowel surgery. However, it should be noted that the devices, systems, and methods of the present application apply in a wide variety of contexts including, but not limited to, other surgical applications. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. Particular examples may be implemented without WO 2025 / 175319                                   PCT / US2025 / 018231 some or all of these specific details. In other instances, well-known operations and / or medical techniques have not been described in detail so as to not unnecessarily obscure the present disclosure. In describing the various devices, systems, and mechanisms of the present disclosure, the description will sometimes describe a connection between two components. Words such as attached, affixed, coupled, connected, and similar terms with their inflectional morphemes are used interchangeably, unless the difference is noted or made otherwise clear from the context. These words and expressions do not necessarily signify direct connections, but include connections through mediate components and devices. It should be noted that a connection between two components does not necessarily mean a direct, unimpeded connection, as a variety of other components may reside between the two components of note. For example, a component of the percutaneous access system of the present disclosure may be described as being slidably disposed within another component, but it will be appreciated that a variety of other tubes, materials, or other components may reside in between the two components of note. Likewise, while a vacuum source may be described herein as being coupled with a vacuum tube of the access system of the present disclosure, it will be appreciated that a variety of bridge devices or componentry may reside between the vacuum source and the vacuum tube. Consequently, a connection does not necessarily mean a direct, unimpeded connection unless otherwise noted. The embodiments of the disclosure described herein are not intended to be exhaustive or to limit the invention to precise forms disclosed. Rather, the embodiments selected for description have been chosen to enable one skilled in the art to practice the disclosure. Furthermore, wherever feasible and convenient, like reference numerals are used in the figures and the description to refer to the same or like parts or steps. The drawings are in a simplified form and not to precise scale. Referring to FIGS. 1-5, a clamping device 100 for use with a vacuum source (not shown) in accordance with the present invention is illustrated. Clamping device 100 comprises an elongated tube 120 having a proximal end 130, a distal end 135, and defining a vacuum channel 140 therein used for suction of a targeted tissue T. The vacuum source (not shown) can be attached to vacuum channel 140 through a vacuum port 142 at the proximal end 130 of tube 120 to provide appropriate suction through vacuum channel 140. Any type of vacuum sources may be used, including a syringe, a controlled vacuum system providing specific suction pressures, etc. The distal end of tube 120 includes an engagement rim 150 having a suction port 160, which is connected to vacuum channel 140, and which is for contacting targeted tissue T. When vacuum is applied through the vacuum channel 140, the target tissue T is pushed into the engagement rim 150 through the suction port 160 as shown in FIG. 6A. Engagement rim 150 may further include at least one radial flange 170 protruding inwardly toward the center of vacuum channel 140 as shown in FIGS. 4A-4D. The embodiment of the clamping device 100 shown in FIGS. 1-5 comprises, for example, but not by way of limitation, eight radial flanges 170 spaced symmetrically around an inner wall of engagement rim 150. However, it is understood that more or fewer radial flanges 170 may be used, or no radial flanges 170 may be used, depending on design specifications, use requirements, and other factors as determined by a person of skill in the art. Tube 120 may also include one or more guide projections 172 on its inner wall extending radially inward, but tube 120 may also have no guide projections 172. Clamping device 100 further comprises an elongated shaft 174 having a proximal end 175, a distal end 176 and a lumen 178 defined therethrough along the length of the shaft 174. A compactor 180 is disposed at the distal end 176 of shaft 174. Compactor 180 may be attached to the distal end 176 of shaft 174 or may be formed integrally with shaft 174. Compactor 180 comprises a proximal end 182 and a distal end 184. Shaft 174 is slidably disposed within the vacuum channel 140 of tube 120 and configured to move between a first position, wherein the distal end 184 of compactor 180 is spaced from the engagement rim 150 of tube 120, as shown in FIG. 5 A, and a second position, wherein the distal end 184 of compactor 180 abuts engagement rim 150, as shown in FIGS. 5B-5C. Compactor 180 includes at least one radial ridge 190 on its outer surface such that when the distal end 184 of compactor 180 abuts engagement rim 150, any tissue pulled into engagement rim 150 will be pinched, or clamped between the engagement rim 150 and the at least one radial ridge 190 when the shaft 174 is in its second position. Referring to FIG. 3, for illustrative example, but not by way of limitation, compactor 180 may be castellated, thereby having a plurality of radial ridges 190 on its outer surface forming channels 195 therebetween. The device 100 may also include a driver 200, which is operably connected to shaft 174 and configured to push and pull shaft 174 along a longitudinal axis within tube 120 between its first and second positions. As shown in FIGS. 1-2, for example, but not by way of limitation, the driver 200 may comprise a threaded nut 201 configured to engage threads 202 on an outer surface of tube 120 and a connector 203 that is fastened to the shaft 174 and engages with threaded nut 201 such that when the threaded nut 201 is rotated it advances up or down the tube 120 and pulls the connector 203 and thus the shaft 174 with it along a longitudinal axis within tube 120 between its first and second positions. The driver 200 may also comprise a spring-loaded driving mechanism that can push and pull shaft 174 along a longitudinal axis within tube 120 between its first and second positions. However, it will be appreciated by those of skill in the art that the driver 200 can be any type of driving mechanism that will drive and retract the shaft 174 between its first and second positions. In use, the tube 120 is inserted into a patient such that the distal end 135 of the tube 120 is in contact with a target tissue site. Once the distal end 135 of tube 120 is in contact with the targeted tissue, the vacuum source is applied to the tube 120 to create suction at the suction port 160 of engagement rim 150 thereby causing tissue T to be pushed through the suction port 160 into the engagement rim 150 by higher external pressure as shown in FIG. 6A. While suction is continuously applied, driver 200 is actuated thereby advancing shaft 174 from its first retracted position towards the distal end 135 of tube 120 to its second engaged position whereby the ridges 190 of compactor 180 engage the engagement rim 150 of tube 120, or the flanges 170 if present, thereby pinching, or clamping the tissue therebetween and holding an area of tissue exposed at the distal opening of the lumen 178 such that it can be accessed through the lumen 178, as shown in FIG. 6B. Referring to FIG. 7, a clamping device 1000 for use with a vacuum source (not shown) in accordance with the present invention is illustrated. Clamping device 1000 comprises a generally cylindrical vacuum hub 1050 defining a lumen therethrough from a distal end 1052 of the vacuum hub 1050 to a proximal end 1054. Vacuum hub 1050 has a vacuum port 1055 therein forming a fluid passageway between the lumen of the vacuum hub 1050 and the exterior of the vacuum hub 1050, and configured to be connected to a vacuum hose 1060, which is connected at one end to the vacuum port 1055 while the other end is configured to be connected to the vacuum source (not shown) allowing a fluid connection between the vacuum source and the lumen of the vacuum hub 1050. Clamping device 1000 further comprises an elongated inner tube 1020 having a distal end 1022 and a proximal end 1024 and defining a lumen therethrough from the distal end 1022 to the proximal end 1024, as shown in FIG. 12. Proximal end 1024 of inner tube 1020 may also have one or more radial protrusions 1026 formed on its outer surface. The inner tube 1020 is positioned in the clamping device 1000 such that the proximal end 1024 of the inner tube 1020 passes through the lumen of the vacuum hub 1050 and the vacuum hub 1050 and the inner tube 1020 are configured to form a seal therebetween. For example, as shown in FIGS. 13-14, vacuum hub 1050 may comprise an inner wall 1056 that defines a first shoulder 1057 and a second shoulder 1058. An o-ring 1080 may be disposed around the inner tube 1020 such that the o-ring 1080 engages the first shoulder 1057 and forms a seal between the inner tube 1020 and the first shoulder 1057. Clamping device 1000 may also comprise a vacuum plug 1085 that is configured to be positioned around the inner tube 1020 and engage the second shoulder 1058. For example, the second shoulder 1058 may be configured as a threaded surface and the outer surface of the vacuum plug 1085 may also be formed as a threaded surface and configured to cooperatively engage the threaded surface of the second shoulder 1058. Referring to FIGS. 7, 8, 9A, 9B, and 15, clamping device 1000 further comprises an elongated outer tube 1030 having a distal end 1032 and a proximal end 1034 and defining a lumen therethrough from the distal end 1032 to the proximal end 1034 which acts as a vacuum channel 1040. The outer tube 1030 is configured to be positioned concentrically over the inner tube 1020 and connecting at its proximal end 1034 to the distal end 1052 of vacuum hub 1050 such that the vacuum channel 1040 is in fluid communication with the lumen of the vacuum hub 1050 whereby application of the vacuum source via the vacuum port 1055 creates suction through the lumen of the vacuum hub 1050 and thus WO 2025 / 175319                                   PCT / US2025 / 018231 through the vacuum channel 1040. Any type of vacuum sources may be used, including a syringe, a controlled vacuum system providing specific suction pressures, etc. The outer tube 1030 and the vacuum hub 1050 may be connected by any known manner that creates enough of a seal between them to prevent leakage of suction when vacuum source is applied. By way of example, but not by limitation, in the embodiment of the clamping device 1000 shown in FIGS. 7, 8, 9A, 9B, and 15, vacuum hub 1050 may comprise a circumferential outer lip 1059 at its distal end 1052, and an o-ring 1081 may be disposed around the distal end 1052 of the vacuum hub 1050 such that the o-ring 1081 engages the lip 1059 and an inner surface of the outer tube 1030forming a seal therebetween. Clamping device 1000 may also comprise a collar 1090 that is positioned over the proximal end 1034 of the outer tube 1030 and configured to be connected to the distal end 1052 of the vacuum hub 1050, for example by threading engagement as seen in FIG. 15, or any similar means, thereby fixing the outer tube 1030 to the vacuum hub 1050. The distal end 1032 of the outer tube 1030 includes an engagement rim 2050 having a suction port 2060, which is open to vacuum channel 1040, and which is for contacting targeted tissue. When vacuum is applied through the vacuum channel 1040, the target tissue is pushed into the engagement rim 2050 through the suction port 2060 by higher external pressure in a similar manner as described above in reference to FIG. 6A. The inner tube 1020 is slidably disposed within the vacuum channel 1040 of outer tube 1030 and configured to move between a first position, wherein the distal end 1022 of inner tube 1020 is spaced from the engagement rim 2050 of outer tube 1030, as shown in FIGS. 9A and 10A, and a second position, wherein the distal end 1022 of inner tube 1020 abuts engagement rim 2050, as shown in FIGS. 9B and 10B. The distal end 1022 of inner tube 1020 may have at least one radial ridge 2090 on its outer surface such that when the distal end 1022 of inner tube 1020 abuts engagement rim 2050, any tissue within engagement rim 2050 will be pinched, or clamped between the engagement rim 2050 and the at least one radial ridge 2090. Referring to FIG. 12, for illustrative example, but not by way of limitation, the distal end 1022 of inner tube 1020 may be castellated, thereby having a plurality of radial ridges 2090 on its outer surface forming channels 2095 therebetween. Alternatively, the at least one radial ridge 2090 may be formed as part of a separate component that is attached to the distal end 1022 of the inner tube 1020 similar to the compactor 180 of clamping device 100 described above. Clamping device 1000 may further comprise a driving mechanism 3000, which is operably connected to inner tube 1020 and configured to push and pull inner tube 1020 along a longitudinal axis between its first and second positions. As shown in FIGS. 16-21, for example, but not by way of limitation, a driving mechanism 3000 in accordance with the present invention may comprise a spring base 3010, a spring 3050, a knob 3060 and a cap 3080. The spring base 3010 is generally cylindrical having a distal portion 3015 and a proximal portion 3030 and defining a lumen therethrough from the distal portion 3015 to the proximal portion 3030. Distal portion 3015 has one or more radial protrusions 3017 formed on its outer surface and one or more slots 3019 formed in its inner surface. The spring base 3010 is disposed on the proximal end 1024 of inner tube 1020 and within the vacuum hub 1050 such that the radial protrusions 1026 on the outer surface of the proximal end 1024 of the inner tube 1020 align with and fit in the one or more slots 3019 in the inner surface of the distal portion 3015 of the spring base 3010, and the one or more radial protrusions 3017 on the outer surface of the distal portion 3015 of the spring base 3010 align with and fit in one or more slots 3020 formed on the inner surface of the vacuum hub 1050. The proximal portion 3030 of spring base 3010 has a diameter that is less than the diameter of the distal portion 3105 such that a shoulder 3022 is formed where the distal portion 3015 and proximal portion 3030 meet. The spring 3050 is positioned on the spring base 3010 over the proximal portion 3030 abutting shoulder 3022. As shown in FIGS. 19 and 21, the knob 3060 comprises a generally cylindrical hollow body with a distal end 3062 having an opening with a diameter sized and shaped to fit over the proximal end 1054 of the vacuum hub 1050, and a proximal end 3064 having an inwardly extending rim 3066 defining an opening with a diameter that is less than the diameter of the opening at the distal end 3062 of the knob 3060. The knob 3060 is rotationally and axially fixed to the vacuum hub 1050 having one or more internal protrusions 3068 extending radially inward that engage with one or more helical thread grooves 3070 in the external surface of the vacuum hub such that rotation of the knob 3060 in one direction causes the knob to move axially towards the distal end 1052 of the vacuum hub 1050, and rotation of the knob 3060 in the opposite direction causes the knob 3060 to move axially towards the proximal end 1054 of the vacuum hub 1050. As shown in FIGS. 20-21, the cap 3080 comprises a generally cylindrical hollow body with a distal end 3082 and a proximal end 3084. The distal end 3082 is connected to the proximal portion 3030 of spring base 3010, for example, via threading on the internal surface of the cap 3080 that engages external threading on the proximal portion 3030 of spring base 3010, or similar means. The cap 3080 also fits over the proximal end 1024 of inner tube 1020 and is fixed to the proximal end 1024 of inner tube 1020. The cap 3080 is sized and shaped such that its distal end 3082 engages the rim 3066 of knob 3060 when the proximal end 3064 of knob 3060 contacts the distal end 3082 of cap 3080. In use, when the knob 3060 is rotated in one direction to move axially towards the distal end 1052 of the vacuum hub 1050, the rim 3066 of the knob 3060 pushes against the spring 3050 which in turn pushes the spring base 3010 and thus the inner tube 1020 axially in the distal direction from its first position, wherein the distal end 1022 of inner tube 1020 is spaced from the engagement rim 2050 of outer tube 1030, to its a second position, wherein the distal end 1022 of inner tube 1020 abuts engagement rim 2050. When the knob 3060 is then rotated in the opposite direction, it moves back axially towards the proximal end 1054 of the vacuum hub 1050. As the knob 3060 moves axially in the proximal direction, the rim 3066 of knob 3060 contacts the distal end 3082 of the cap 3080 pushing the cap 3080 in the proximal direction, and the cap 3080 thereby pulling the inner tube 1020 in the proximal direction from its second position back to its first position. However, it will be appreciated by those of skill in the art that the driving mechanism 3000 can be any type of driving mechanism that will drive and retract the inner tube 1020 between its first and second positions. Referring to FIGS. 22a-22B, clamping device 1000 may also include a stabilizing ring 4000, which is axially and rotationally mounted on the outer tube 1030. More specifically, the stabilizing ring 4000 may have internal threading that engages with threading on the external surface of outer tube 1030 such that rotation of the stabilizing ring 4000 in one direction causes the ring 4000 to move distally along the longitudinal axis of outer tube 1030, and rotation of the ring 4000 in the opposite direction causes the ring 4000 to move proximally along the longitudinal axis of outer tube 1030. The stabilizing ring 4000 has a radial flange 4002 at its distal end that extends outwardly defining a contact surface 4004. In use, when the clamping device 1000 is in place and engaged with target tissue in a patient, the stabilizing ring 4000 can be rotated to advance it distally until the contact surface 4004 engages the body of the patient thereby stabilizing the device 1000 against certain inadvertent movement during the surgery, or other medical procedure. The lumen of inner tube 1020 provides a central access channel of the device 1000 through which therapeutic and / or diagnostic substances, wires, needles, cameras, additional surgical instruments, other equipment and / or devices, etc. can be delivered to the target tissue. Alternatively, clamping device 1000 may further comprise an elongated shaft 1074 having a proximal end 1075, a distal end 1076 and a lumen 1078 defined therethrough along the length of the shaft 1074, the elongated shaft 1074 being disposed within the lumen of the inner tube 1020 such that the shaft lumen 1078 provides the central access channel. In at least one embodiment of a percutaneous access system for use with a vacuum source for percutaneously accessing and securing target tissue / organs within a patient (including in the small intestine and any part of the intestine) of the present disclosure, the system comprises a clamping device, for example, as described herein, a trocar having an awl (which may be metal or plastic with a pointed or tapered tip) and a rigid, hollow cannula tube, and may be configured for advancement through the abdominal wall of a patient. The following description of use of a clamping device 1000 of the kind disclosed herein will be in the context of providing access to the small intestine (SI), but it is understood that the clamping device 1000 can be used to provide access to any internal organ. In use, a needle is inserted (e.g., a Veress open tip needle) through the abdominal wall. A guidewire is placed through the needle and across the abdominal wall. Contrast and methylene blue may be injected. The needle is removed leaving the guidewire. A trocar having an awl and a rigid, hollow cannula tube is advanced over the guidewire and across the abdominal wall. The awl is then removed leaving the cannula in place. A clamping device 1000 is then advanced over the guidewire and through the cannula of the trocar such that the distal end 1032 of the outer tube 1030 of the device 1000 contacts an external surface of the SI. When advancing the access device, the method may further include using a camera, or scope to guide the access device. Using a vacuum source operably connected to the device 1000, suction is applied to the vacuum channel 1040 via the vacuum hub 1050 to create suction at the suction port 2060 of engagement rim 2050 thereby causing tissue of the external surface of the SI to be pushed through the suction port 2060 into the engagement rim 2050 by higher external pressure. While suction is continuously applied, driving mechanism 3000 is actuated by rotating the knob 3060 causing the knob 3060 to move axially in a distal direction thereby advancing inner tube 1020 (as described above) from its first retracted position towards the distal end 1032 of outer tube 1030 to its second engaged position where the distal end 1022 of inner tube 1020, and the radial ridges 2090 thereon, abut engagement rim 2050, such that any tissue of the external surface of the SI within engagement rim 2050 will be pinched, or clamped between the engagement rim 2050 and the radial ridges 2090 thereby securing the SI to distal end of device 1000, and holding a target area of the wall exposed at the suction port 2060 such that it can be accessed through the central access channel of the device 1000. The stabilizing ring 4000 can then be advanced along the outer tube 1030 until it contacts the abdomen of the patient further stabilizing the device 1000 during surgery. The access site of the SI wall is held securely and continuously to the outer tube 1030 to provide a stabilized area through which instruments (such as introducer sheath, endoscope, dilation balloon, or closure device) can be inserted. After diagnosis or treatment, a closure device will be introduced through the central access channel of the device 1000, or alternatively, a closure device will be incorporated into the access device. While various embodiments of devices and systems for percutaneously accessing and securing target tissue / organs within a patient and methods for the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof. Further, in describing representative embodiments, the present disclosure may have presented a method and / or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and / or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and remain within the scope of the present disclosure.

Claims

1. A percutaneous access device for use with a vacuum source for accessing and releasably engaging internal bodily tissue, comprising:an elongated tube having a proximal end, a distal end, and a vacuum channel defined therethrough operably coupling the proximal and distal ends;a vacuum port in communication with the vacuum channel and capable of operative connection to the vacuum source thereby creating suction within the vacuum channel;an inwardly extending rim disposed at the distal end of the elongated tube defining an aperture at the distal end of the elongated tube to engage a tissue of interest, the aperture being operably coupled to the vacuum channel such that the suction within the vacuum channel will cause the tissue to be pushed through the aperture and at least partially into the distal end of the elongated tube by higher external pressure;a clamp element having an outer surface and an inner surface, the inner surface defining a lumen therethrough extending from an aperture at a proximal end of the clamp element to an aperture at a distal end of the clamp element, the clamp element being coaxially disposed in the vacuum channel of the elongated tube and configured to move between at least a first position and a second position, wherein when the clamp element is in the first position, the outer surface at the distal end of the clamp element is spaced apart from the rim at the distal end of the elongated tube, and when the clamp element is in the second position, the outer surface at the distal end of the clamp element is adjacent the rim at the distal end of the elongated tube such that any tissue that is at least partially within the distal end of elongated tube is pinched between the outer surface at the distal end of the clamp element and the rim of the elongated tube.

2. The percutaneous access device of claim 1, wherein the outer surface at the distal end of the clamp element comprises at least one ridge extending radially outward from the outer surface, and wherein when the clamp element is in the second position, the at least one ridge is adjacent the rim at the distal end of the elongated tube such that any tissue that is at least partially within the distal end of elongated tube is pinched between the at least one ridge and the rim of the elongated tube.

3. The percutaneous access device of claim 2, wherein the at least one ridge comprises a plurality of ridges, the plurality of ridges defining channels therebetween, and wherein when the clamp element is in the second position, the plurality of ridges are adjacent the rim at the distal end of the elongated tube such that any tissue that is at least partially within the distal end of elongated tube is pinched between the plurality of ridges and the rim of the elongated tube.

4. The percutaneous access device of claim 3, wherein the rim comprises an interior surface and a number of flanges on the interior surface of the rim equal to the number of channels on the outer surface at the distal end of the clamp element, the flanges being configured to cooperativelyinteract with the channels such that when the clamp element is in the second position any tissue that is at least partially within the distal end of elongated tube is pinched within the channels between the flanges and the ridges.

5. The percutaneous access device of claim 1, further comprising:a driving mechanism operatively connected to the clamp element, wherein the driving mechanism is configured to move the clamp element between the first and second positions.

6. The percutaneous access device of claim 1, wherein the clamp element comprises an inner elongated tube.

7. The percutaneous access device of claim 1, further comprising:an elongated shaft with a distal end and a proximal end defining an access channel therethrough extending from an aperture at the proximal end of the shaft to an aperture at the distal end of the shaft, wherein the elongate shaft is disposed coaxially within the lumen of the clamp element.

8. A percutaneous access device for use with a vacuum source for accessing and releasably engaging internal bodily tissue, comprising:a vacuum hub having a distal end, a proximal end and a cylindrical bore therethrough defining a lumen extending from the proximal end to the distal end, the vacuum hub having a vacuum port defining a passageway from the exterior of the vacuum hub to the lumen of the vacuum hub;an outer tube having a proximal end, a distal end, and a vacuum channel defined therethrough operably coupling the proximal and distal ends, the proximal end of the outer tube being connected to the distal end of the vacuum hub thereby operably coupling the vacuum channel and the lumen of the vacuum hub;wherein the vacuum port in the vacuum hub is capable of operative connection to the vacuum source thereby creating suction within the lumen of the vacuum hub and the vacuum channel of the outer tube;wherein the outer tube comprises an inwardly extending rim disposed at the distal end of the outer tube defining an aperture at the distal end of the outer tube to engage a tissue of interest, the aperture being operably coupled to the vacuum channel such that any tissue of interest engaged by the aperture at the distal end of the outer tube can be pushed through the aperture and at least partially into the distal end of the elongated tube;an inner tube having a proximal end, a distal end, and a lumen defined therethrough operably coupling the proximal and distal ends of the inner tube, the inner tube being slidably disposed within the vacuum channel of the outer tube and the lumen of the vacuum hub and configured to move between at least a first position and a second position, wherein when the inner tube is in the first position, the distal end of the inner tube is spaced apart from the rim at the distal end of the outer tube, and when the inner tube is in the second position, the distal end of the inner tube is adjacent the rim atthe distal end of the outer tube thereby creating a clamping effect between the distal end of the inner tube and the rim at the distal end of the outer tube.

9. The percutaneous access device of claim 8, wherein the distal end of the inner tube comprises at least one ridge extending radially outward, and wherein when the inner tube is in the second position, the at least one ridge is adjacent the rim at the distal end of the outer tube thereby creating a clamping effect between the at least one ridge at the distal end of the inner tube and the rim at the distal end of the outer tube.

10. The percutaneous access device of claim 9, wherein the at least one ridge comprises a plurality of ridges, the plurality of ridges defining channels therebetween, and wherein when the inner tube is in the second position, the plurality of ridges are adjacent the rim at the distal end of the outer tube thereby creating a clamping effect between the plurality of ridges at the distal end of the inner tube and the rim at the distal end of the outer tube.

11. The percutaneous access device of claim 10, wherein the rim comprises an interior surface and a number of flanges on the interior surface of the rim equal to the number of channels between the plurality of ridges at the distal end of the inner tube, the flanges being configured to cooperatively interact with the channels such that when the inner tube is in the second position the flanges on the interior surface of the rim engage with the channels between the plurality of ridges at the distal end of the inner tube.

12. The percutaneous access device of claim 8, further comprising:a driving mechanism operatively connected to the inner tube, wherein the driving mechanism is configured to move the inner tube between the first and second positions.

13. A method for using a percutaneous access device for use with a vacuum source to accessand engage an internal organ, the method comprising the steps of:inserting a needle into a patient at or near the internal organ;advancing a guidewire through the needle;removing the needle while leaving the guidewire;advancing a clamping device over the guidewire, wherein the clamping device comprisesa vacuum hub having a distal end, a proximal end and a cylindrical bore therethrough defining a lumen extending from the proximal end to the distal end, the vacuum hub having a vacuum port defining a passageway from the exterior of the vacuum hub to the lumen of the vacuum hub;an outer tube having a proximal end, a distal end, and a vacuum channel defined therethrough operably coupling the proximal and distal ends, the proximal end of the outer tube being connected to the distal end of the vacuum hub thereby operably coupling the vacuum channel and the lumen of the vacuum hub;wherein the vacuum port in the vacuum hub is capable of operative connection to the vacuum source thereby creating suction within the lumen of the vacuum hub and the vacuum channel of the outer tube;wherein the outer tube comprises an inwardly extending rim disposed at the distal end of the outer tube defining an aperture at the distal end of the outer tube to engage a surface of the organ, the aperture being operably coupled to the vacuum channel;an inner tube having a proximal end, a distal end, and a lumen defined therethrough operably coupling the proximal and distal ends of the inner tube, the inner tube being slidably disposed within the vacuum channel of the outer tube and the lumen of the vacuum hub and configured to move between at least a first position and a second position, wherein when the inner tube is in the first position, the distal end of the inner tube is spaced apart from the rim at the distal end of the outer tube, and when the inner tube is in the second position, the distal end of the inner tube is adjacent the rim at the distal end of the outer tube thereby creating a clamping effect between the distal end of the inner tube and the rim at the distal end of the outer tube;positioning the clamping device such that the aperture at the distal end of the outer tube contacts an external surface of the organ;applying suction to the vacuum channel of the outer tube via the vacuum hub to create suction at the aperture in the rim at the distal end of the outer tube thereby causing at least a portion of the external surface of the organ to be pushed through the aperture by higher external pressure and at least partially into the distal end of the outer tube;driving inner tube from the first position to the second position thereby pinching the external surface of the organ between the distal end of the inner tube and the rim of the outer tube and holding a portion of the external surface of the organ at the aperture at the distal end of the outer tube which can be accessed through the lumen of the inner tube.

14. A method for using a percutaneous access device for use with a vacuum source to accessand engage an internal organ, the method comprising the steps of:inserting a needle into a patient at or near the internal organ;advancing a guidewire through the needle;removing the needle while leaving the guidewire;advancing a trocar having an awl and a rigid, hollow cannula tube over the guidewire;removing the awl leaving the cannula in place;advancing a clamping device over the guidewire and through the cannula, wherein the clamping device comprisesWO 2025 / 175319                                   PCT / US2025 / 018231a vacuum hub having a distal end, a proximal end and a cylindrical bore therethrough defining a lumen extending from the proximal end to the distal end, the vacuum hub having a vacuum port defining a passageway from the exterior of the vacuum hub to the lumen of the vacuum hub;an outer tube having a proximal end, a distal end, and a vacuum channel defined therethrough operably coupling the proximal and distal ends, the proximal end of the outer tube being connected to the distal end of the vacuum hub thereby operably coupling the vacuum channel and the lumen of the vacuum hub;wherein the vacuum port in the vacuum hub is capable of operative connection to the vacuum source thereby creating suction within the lumen of the vacuum hub and the vacuum channel of the outer tube;wherein the outer tube comprises an inwardly extending rim disposed at the distal end of the outer tube defining an aperture at the distal end of the outer tube to engage a surface of the organ, the aperture being operably coupled to the vacuum channel;an inner tube having a proximal end, a distal end, and a lumen defined therethrough operably coupling the proximal and distal ends of the inner tube, the inner tube being slidably disposed within the vacuum channel of the outer tube and the lumen of the vacuum hub and configured to move between at least a first position and a second position, wherein when the inner tube is in the first position, the distal end of the inner tube is spaced apart from the rim at the distal end of the outer tube, and when the inner tube is in the second position, the distal end of the inner tube is adjacent the rim at the distal end of the outer tube thereby creating a clamping effect between the distal end of the inner tube and the rim at the distal end of the outer tube;positioning the clamping device such that the aperture at the distal end of the outer tube contacts an external surface of the organ;applying suction to the vacuum channel of the outer tube via the vacuum hub to create suction at the aperture in the rim at the distal end of the outer tube thereby causing at least a portion of the external surface of the organ to be pushed through the aperture by higher external pressure and at least partially into the distal end of the outer tube;driving inner tube from the first position to the second position thereby pinching the external surface of the organ between the distal end of the inner tube and the rim of the outer tube and holding a portion of the external surface of the organ at the aperture at the distal end of the outer tube which can be accessed through the lumen of the inner tube.

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